Sensor-based Assessment and Rehabilitation of Balance in Neurological Diseases
NCT ID: NCT04874051
Last Updated: 2023-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2019-09-02
2023-12-31
Brief Summary
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Detailed Description
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OAK Elderly Care System consists of two independent balance boards and three sensors for the kinematic tracking of the trunk and lower limbs. These components allow the assessment of the centre of pressure and the execution of exercises in a virtual environment.
120 patients (40 stroke, 40 MS, 40 PK) hospitalized at 4 different italian hospitals, were enrolled according to inclusion and exclusion criteria and randomly assigned to two groups (i.e. intervention group, control group). Intervention group received 1 daily hour of technology-based treatment, while the control group underwent 1 daily hour of physiotherapy for balance rehabilitation, in addiction to 1 hour of conventional physiotherapy. Both treatments lasted 15 sessions. Before and after treatment balance, walking, daily living autonomy and pathology-specific features were assessed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental Group (EG)
In the EG the subjects will perform balance exercises using the OAK system under the supervision of a trained physiotherapist. The treatment will last 3 weeks with daily sessions of 60 minutes, 5 times per week.
Experimental Group
The experimental treatment will be provided by means of the OAK system. This device consists of 1 cabinet with 2 independent balance boards, 2 monitors (one for the physiotherapist and one for the patient) and 3 wireless IMUs (one for the left lower limb, one for the right lower limb and one for the trunk). The 2 balance boards provide body weight transfer exercises, while the wireless motion sensors provide one leg stance exercises or trunk exercises in a virtual environment.
Control Group (CG)
In the CG the subjects will be asked to perform conventional balance exercises under the supervision of a physiotherapist. The treatment will last 3 weeks with daily sessions of 60 minutes, 5 times per week.
Control Group
The Control Group will perform conventional balance exercises similar to the exercises provided with the OAK system.
Interventions
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Experimental Group
The experimental treatment will be provided by means of the OAK system. This device consists of 1 cabinet with 2 independent balance boards, 2 monitors (one for the physiotherapist and one for the patient) and 3 wireless IMUs (one for the left lower limb, one for the right lower limb and one for the trunk). The 2 balance boards provide body weight transfer exercises, while the wireless motion sensors provide one leg stance exercises or trunk exercises in a virtual environment.
Control Group
The Control Group will perform conventional balance exercises similar to the exercises provided with the OAK system.
Eligibility Criteria
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Inclusion Criteria
* Berg Balance Scale \< 50/56;
* Ability to maintain the standing position with o without one support for 1 minute;
* Functional Independence measure \< 100/126;
* Barthel Index \< 80/100.
Stroke:
* Single ischemic stroke;
* Lesion occured after 2 and within 18 months;
* National Institute of Health Stroke Scale ≤ 14.
Parkinson:
* 1.5 \< Hoehn \& Yahr \< 3;
* Subitem "freezing when walking"of the UPDRS ≤ 2.
Multiple Sclerosis:
* Relapsing remitting or secondary progressive Multiple Sclerosis;
* Expanded Disability Status Scale ≤ 6.5.
Exclusion Criteria
* Major depressive disorder;
* Fractures;
* Dementia;
* Ideomotor Apraxia;
* Neglect;
* Severe impairment of verbal comprehension;
* Severe acoustic and visual disorders.
18 Years
90 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Istituti Clinici Scientifici Maugeri SpA
OTHER
IRCCS National Neurological Institute "C. Mondino" Foundation
OTHER
I.R.C.C.S. Fondazione Santa Lucia
OTHER
IRCCS San Camillo, Venezia, Italy
OTHER
Responsible Party
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Principal Investigators
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Andrea Turolla, PhD
Role: PRINCIPAL_INVESTIGATOR
San Camillo IRCCS
Locations
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IRCCS Fondazione Mondino
Pavia, , Italy
IRCCS ICS Maugeri Spa SB
Pavia, , Italy
IRCCS San Raffaele Pisana
Rome, , Italy
IRCCS Fondazione Santa Lucia
Rome, , Italy
San Camillo IRCCS
Venice, , Italy
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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1099/IRCCS San Camillo
Identifier Type: -
Identifier Source: org_study_id
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